Department of Internal Medicine, Monmouth Medical Center, Long Branch, NJ
Farhan Khalid , Richi Kashyap , Vinit Singh , Muhammad Tayyeb , Ali Jaan , Gaurav Mohan , Trishala Meghal
Background: Sacituzumab govitecan (SG) is an drug-antibody conjugate composed of anti-trophoblast cell-surface antigen 2 (Trop-2) IgG1 Kappa antibody with SN-38 through a hydrolysable linker. SG has a promising efficacy safety profile in triple negative breast cancer (TNBC) and was given regular approval for nonresectable locally advanced or metastatic disease with 2 or more previous line of therapies. This review aims to explore the efficacy and safety of SG-regimens for the treatment of TNBC. Methods: We conducted a literature search using three databases (PubMed, Embase, and ClinicalTrials.gov). Our search strategy included MeSH and keywords for breast cancer and SG including trade and generic names from the date of inception to January 15, 2022. Initial databases yielded 275 articles. After exclusion, two clinical trials on the use of SG in pretreated TNBC were included. Results: Among a total of 963 enrolled patients, 379 patients were evaluated. Majority of the patients received SG dose of 10 mg/kg. Bardia et al. studied the efficacy of SG in TNBC pts (n = 235) in phase III (ASCENT) trial achieved an overall response rate (ORR) of 31%. The median overall survival (OS) was 11.8 months (95% CI 10.5-13.8) and a median progression-free survival (PFS) was 4.8 months (95% CI, 4.1-5.8).Similarly, in another study Bardia et al. studied SG in TNBC pts (n = 144) in phase I/II (basket) trial and observed ORR of 33.3%. The median overall survival (OS) was 13 months (95% CI, 11.2 to 14) and a median progression-free survival (PFS) was 5.6 months (95% CI, 4.8 to 6.6). (Table) Diarrhea and Nausea was the most common adverse effect reported by the patient whereas neutropenia was the most common grade 3 adverse effect. Conclusions: SC showed promising outcomes in terms of ORR for the treatment of TNBC.
Trial ID | Author, Year; Phase | Regimen | N(n) | Response rates | Survival | Disease status | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
ORR % | CR % | PR % | HR for death | Median time to response | CBR % | OS (mo) | mPFS (mo) | SD % | PD % | ||||
NCT02574455 | Bardia et al. 2021/ Phase III | Sacituzumab | 468 (235) | 31 | 4 | 27 | 0.51 (0.41–0.62 | 1.5 (0.7–10.6) | 40% | 11.8 (10.5–13.8) | 4.8 (4.1–5.8) | 36 | 24 |
NCT01631552 | Bardia et al. 2021/ Phase 1/11 | Sacituzumab | 495 (144) | 33.3 (CI, 24.6-43.1) | 2. | 30.6 | N/A | N/A | 49 (45.4) [35.8-55.2] | 13.0 (11.2-14.0) | 5.6 (4.8-6.6) | 37% | N/A |
Author, Year, Phase | Toxicities (any grade) | Toxicities (Grade≥3) | ||
---|---|---|---|---|
Hematological (%) | Non-hematological (%) | Hematological (%) | Non-hematological (%) | |
Bardia et al, 2021, Phase III | Neutropenia 63% Leukopenia 16% Anemia 34% | Diarrhea 59% Nausea 57% Fatigue 45% Alopecia 46% vomiting 29% | Neutropenia 51% | |
Bardia et al, 2021, Phase I/II | Neutropenia 57.8% Anemia 34.9% Febrile neutropenia 5.5% | Nausea 62.6% Diarrhea 56.2% Vomiting 38.6% Fatigue 48.3% Alopecia 40.4% | Neutropenia 42.4% |
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Abstract Disclosures
2022 ASCO Annual Meeting
First Author: Indrajeet Singh
2022 ASCO Annual Meeting
First Author: Qiao Li
2022 ASCO Annual Meeting
First Author: Aditya Bardia
2024 ASCO Annual Meeting
First Author: Jonathan N. Priantti